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Monoclonal Antibodies

CSJ117 for Asthma

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants entering directly after completion of study treatment of core study: weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; participants entering directly after completion of the core study follow-up period: weeks 2, 4, 8, 12, 14, 16 and 24.

Summary

This trial tests the safety and effectiveness of an inhaled medication called CSJ117 in adult asthma patients who are already on strong asthma treatments. The study will see how well the body handles the drug and if it causes any immune reactions.

Eligible Conditions

Asthma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants entering directly after completion of study treatment of core study: weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; participants entering directly after completion of the core study follow-up period: weeks 2, 4, 8, 12, 14, 16 and 24.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants entering directly after completion of study treatment of core study: weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; participants entering directly after completion of the core study follow-up period: weeks 2, 4, 8, 12, 14, 16 and 24.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants entering directly after completion of study treatment of core study: weeks 2, 4, 8, 12, 14, 16, 20, 24, 26, 28 and 36; participants entering directly after completion of the core study follow-up period: weeks 2, 4, 8, 12, 14, 16 and 24. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs)

Number of treatment emergent participant deaths and participant hospitalizations

Secondary study objectives

CSJ117 serum concentration

Change from baseline in Anti-drug immune response

Change from baseline in Fractional exhaled Nitric Oxide (FeNO) levels

+2 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: 24-week CSJ117Experimental Treatment1 Intervention

Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated once daily for 24 weeks with the same dose of CSJ117 they received in the core study. CSJ117 (0.5 mg, 1 mg, 2 mg, 4 mg and 8 mg) inhaled once daily for 24 weeks.

Group II: 12-week wash out + 12-week CSJ117Experimental Treatment1 Intervention

Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated with Placebo inhaled once daily for 12 weeks "washout period" and then they will be treated once daily for 12 weeks with the same dose of CSJ117 they received in the core study. CSJ117 (0.5 mg, 1 mg, 2 mg, 4 mg and 8 mg) inhaled once daily for 12 weeks.

Group III: 12-week CSJ117Experimental Treatment1 Intervention

Participants who will enter the extension study after the last follow-up visit (week 24) of the core study will be treated with once daily for 12 weeks with the same dose of CSJ117 they received in the core study. CSJ117 (0.5 mg, 1 mg, 2 mg, 4 mg and 8 mg) inhaled once daily for 24 weeks.

Group IV: 24-week PlaceboPlacebo Group2 Interventions

Participants who will enter the extension study after the last treatment visit (week 12) of the core study and will be treated with Placebo inhaled once daily for 24 weeks

Group V: 12-week wash out + 12-week PlaceboPlacebo Group1 Intervention

Group VI: 12-week PlaceboPlacebo Group1 Intervention

Participants who will enter the extension study after the last follow-up visit (week 24) of the core study will be treated with Placebo inhaled once daily for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CSJ117

2021

Completed Phase 2

~70

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